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I have had a chance to visit with Dr. Faustman. Here is some information I gathered that might be helpful. The FDA did limit Faustman/Nathan to two doses in the Phase I trial. MGH had originally wanted to do 6 doses but the FDA did not allow that for safety reasons. The Faustman lab and the MGH are experienced at dosing trials and although the protocols are approved within Harvard it is too early to speculate what the FDA will advise for Phase II. All need to wait to see what Faustman/MGH want and what the FDA will allow. Remember that in general the FDA is ONLY interested in SAFETY so it is likely that they will come at the Phase II trial from the safety view point. Faustman/MGH will advocate for a therapeutic outcome. Lastly, keep in mind that the two doses of BCG for multiple sclerosis (Phase II trials) showed amazing effects when patients are followed out 5 years so the BCG drug can have long lasting therapeutic effects in autoimmunity that are now are allowing Phase III testing for that disease. The BCG scientific community has had and does have interactive scientific exchange trying to use this cheap drug and the progress in humans with autoimmunity is progressing very rapidly. If Faustman needs help then I am sure Faustman will work with the supportive lay community for help. Bruce: Thank you for your comment to our Newsletter #8 – “The Skinny on Faustman’s Phase II”. Especially relevant is your statement that the FDA limited Phase I to 2 doses of BCG instead what was requested by the Faustman Lab, which was 6. Many people still think the FDA simply approves what the researcher requests. This is not the case here. You mention that “…the FDA is only interested in safety…” As you probably guessed, we don’t believe the FDA limited Phase I to two doses because of safety. In the last 2 newsletters we’ve proven that BCG has been used at 2 doses for TB and multiple doses for Bladder Cancer with no negative effects in the long term. “The Faustman lab and the MGH are experienced at dosing trials … and the protocols are approved within Harvard …” Yes, we wonder why the FDA doesn’t recognize this fact. You said also “… keep in mind that the two doses of BCG for multiple sclerosis (Phase II trials) showed amazing effects when patients are followed out 5 years …) We feel this study and Dr. Faustman’s can’t readily be compared because the MS study used interferon-β-1a before BCG. We can’t assume the combined effects of two compounds would be the same as BCG alone. Also even though both diseases are auto-immune, both diseases could require different dosages/frequencies. You can see the MS study here: http://www.neurology.org/content/early/2013/12/04/01.wnl.0000438216.93319.ab.abstract The results of this study was very minor – a reduction of a small number of lesions. Not a single complete reversal… just a slight reduction of the MS progression. Dr. Faustman’s research aims to reverse type 1 diabetes completely…not just reduce insulin by 1 unit. The general public wants a cure in the shortest period of time. Why not give a therapeutic dose i.e. several successive doses to tolerance to begin with? Why wait 5 years? Surely a cure is more important than going over the safety issue again. Many drugs that are proven safe are often fast-tracked for another condition at a fraction of the cost. Again thank-you for those very interesting facts, but we just don’t agree with you that the FDA is operating with the public interest as its primary purpose. We believe that they are using their indemnity as a smoke-screen forcing bad methodology in research, in order that cures NOT be found. They should be utterly ashamed of themselves for not following scientific precedents and for sloppy scientific reasoning. The Editors, Hdiabetes.com

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Terrific Newsletter #8 analyses you folks researched and published (sent a copy to Dr Faustman & Team for comment, Bcc to you)...BUT, why WHY do you all remain anonymous??? You're promoting a hopeless (IMHO) grass-roots effort by your (relatively handful of mostly diabetic) readers, but to what effect if you're not willing to even expose and publish who you are? To successfully challenge a deeply entrenched federal bureaucracy in-bed with big pharma will require tons more support from more deep-pocket philanthropists, major and continuous bi-partisan media attention, the medical professions' plus ADA, JDRF, etc. consensus support, and politically powerful spokesmen and women from inside and outside the feds to even begin to have a chance of a proverbial snowball in hell of changing the system! But how can you, we, or anyone get the backing and support needed if you guys don't sign up with your name, rank and serial number to kick things off with? A just and long-neglected cause such as ours requires every ounce of muscle we can muster nation-wide to have any hope of prevailing, so please help me understand your reluctance if you don't agree.. --------------------------------- Dear Bill, Thanks for bcc us on your email to the Faustman lab. We are not averse to them knowing about our nsl. I'm sure they truly do want a better methodology but are restricted by the FDA. We have had several confirmations from sources near Dr. Faustman that she is currently negotiating to change the current FDA approved Phase 2 methodology. However Dr. Faustman can't do it alone. The FDA won't listen to her. But if there is public opinion behind her then change is more likely. The question is: how can we get as many people knowing about this issue as possible in order to put pressure on the FDA or even higher -- to government or even Congress. You're right, this is a small grass roots effort read mostly by diabetics. So we need to expand our story to reach absolutely everyone we can. The tactics of the FDA effect everyone. You said how can we get the support of the larger society if we don't identify ourselves? Firstly, Hdiabetes.com's mission is a collaborative effort, not an individual one. Secondly please be aware that anyone who goes against the will of established corporations, be it in the energy sector (so many energy saving devices just gathering dust in corporate files), the food sector, or in the pharmaceutical sector, are harassed or worse. There have been many, many examples of this. But then, as you say, how can we promote our cause to the higher-ups? It would be ideal if we could find a public figure to support our mission but we don't as yet have one If anyone out there is interested, please let us know. Other than that, we're doing the only thing we can do, and that is telling everyone we know. We will contact other groups concerned with honesty in research and encourage our readers to do the same. Also, we are starting entries on Facebook and Twitter, and encourage our readers to use these social networks to get the word out to individuals and organizations. You're right in saying ours is a just and long-neglected cause and that we need every ounce of muscle to prevail. Thank you for your comment Bill.

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I injected about 50 adult doses into my arm in 2012, intravenously, to try and cure myself. It was insanely painful and got infected where the BCG flowed out into my forearm under the skin. My forearm still has three large, red, stained marks along the veins, where I did the injections, even two years later I still wear long sleeve shirts to work because it makes me look like a junkee. I rarely go to barbecues or wear T shirts for any reason, except indoors. I have no idea what Faustman's research is now about, but it didn't work for me. I tested myself after taking the first three small doses in my upper arm under the skin, to test it, and then tested for C-peptides but didn't notice any difference. Then I did the huge injections and my blood sugar didn't improve, if anything it got worse for a while as happens when you have a cold. I did some gad antibody tests and I don't have any, and some other antibody tests too and it looks like my diabetes isn't even true type 1, but some kind of hybrid idiopathic type1b that isn't autoimmune. Either that or my antibodies died away long ago because my pancreas is totally dead, and there isn't a single living beta cell inside me. Maybe if I got some regenerative medecine to start them growing again I could be cured easier than most type 1s now, or maybe it will come back with a vengeance. Anyway, I hope they find a cure soon, my health is deteriorating with age and I'm losing hope. _____________________ Dear Hoping4cure, I remember reading about your experiments using BCG. That's why we've come to the conclusion that it's NOT a good idea to try BCG treatment on your own. Dr Faustman's research is restricted to diabetes type 1 auto-immune.. Type 1b or idiopathic is not in this research. One of inclusion criteria of this research is to test positive to anti-gad anti-bodies and low c-peptide. It's the common clinical practice to confirm type 1 auto-immune. You need have both. Anti-gad positive and low c-peptide level to confirm type 1 auto-immune. Type 1b could have several causes like genetic, inflammation, hormone imbalance from the other organs,pancreatitis, side effect of past medical drugs,etc... so it's complex.. The best chance for you is to find a doctor specialist worldwide that could establish a strong diagnostic. After you have a strong diagnostic, you could determine the best course of treatment and potential cure suitable for your specific type 1b. Animal insulin could be better to help you to stabilize your diabetes as well. The reason for this is that the METHODOLOGY or PROTOCOL of treatment with BCG is very important. That means the amount given, how its given, and when it's given must all be taken into consideration. Even the nurses could make mistakes in the injection technique resulting in severe skin reaction. Compare to one person alone without a proper medical training it increases the risk of severe skin reaction. It is very small health issue even with severe skin reaction that will impact more your appereance than your overall long-term health. In the researches they showed with a proper injection technique of bcg you almost virtually eliminate the skin reaction and some injection sites are better than other. BCG is a vaccine that is prepared from a strain of the attenuated (virulence-reduced) live bovine tuberculosis bacillus. Dr. Faustman in her patent recommended 2 or 3 doses per week DEPENDING ON BIOMARKERS. Knowing the biomarkers are essential because one can then see how the immune system is responding to the BCG -- whether it is producing C-peptides or anti-GAD,bad t-cells, killed bad t-cells , etc. The biomarkers indicate very different things, and determine the time and amount of the next dose. The methodology is more important than the compound itself to cure diabetes type 1. It's interesting to note that though biomarkers are essential in determining pancreatic response, the FDA did not allow Faustman to adjust the dosages of bcg according the biomarkers in Phase 1 and will not allow it in Phase 2 as well. If a simple blood test indicating such important information in treatment is not allowed, the glaring question is: WHY? Hope this helps and thanks for your comment. Editors, Hdiabetes.com

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As a type I diabetic for I don't know how many years (20+), I've been always told that a cure would be found within five years. Many five years have passed and we have nothing. I was also told many times that a cure (many, in fact) was found, but the FDA was suppressing it by bullying the researchers or providing them with more money than the cure ever would so that they halt the research process. I really don't know what you can do to fight an invisible enemy that actually is nothing more than a collection of each of us: The FDA is a by-product of capitalism and we people are what feed capitalism. We should have power over this enemy... Maybe diabetics of all types from all over the world should unite and go on a strike of some sort. That's the only thing I can think of. Or I personally don't see a cure for diabetes in the short term UNLESS A MORE PROFITING EPIDEMIC COMES INTO BEING TO FEED THIS MONSTER. __________________ Dear Aykut, Thank- you for your thoughtful comment. I'm going to disagree with your comment that the bullying tactics of Pharma/Fda are like all of us. If it were up to me, I would want real research to find a real cure, and I know you would too. I don't want to believe that the heartless system of capitalism that the rich and powerful have fashioned can't be changed somehow to be more compassionate. I believe it starts with communication. Before the internet we never even heard about the abuses of power in our system. It's true we still don't know exactly what to do to implement a lot of things, but many things HAVE been accomplished since the 99% have been able to communicate on the internet. Brainstorming is the first step in finding solutions. Maybe we should have online votes for issues that require change. I was also thinking that if we had independent medical people saying that the dosage of BCG that is currently used for Bladder Cancer, is safe to use for Faustman's Phase 2, then we can call out the FDA to justify their reason. If they can only explain in scientific gobildy-gook and not in plain language, then we can protest further. The fact is that we may think something's impossible, but in actuality, we don't KNOW what IS possible. Until we brainstorm, like you have Aykut, and try something new. The internet has put a whole new spin on what can be done, wouldn't you say? Thanks you so much for your post. Keep on connecting and brainstorming! Best Regards, The Editors, Hdiabetes.com

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It seems that your main goal is to boost and enhance the immune system that is impaired badly leading to the destruction of beta cells partially or totally. Wish you complete success in this way. __________________ Hi, Thanks for your comment, but we're not the Faustman Lab. (learn more about it at www.faustmanlab.org. On this website we're informing people of the difficulties an independent researcher has WITHOUT A GRANT FROM THE PHARMACEUTICALS. All pharmaceuticals have REFUSED to fund Dr. Faustman's studies. Why? we asked, when such a knowledgeable and esteemed researcher has already found a cure for Dt1 in mouse studies? The answer, we found after much study, is that Pharma funds only studies that will BRING THEM MORE PROFIT. And the finding of a cure -- incidentally t here are many cures that have been found for many other diseases -- WILL CUT PROFITS. So, in other words, because of the system as it stands now, cures will never be allowed to be activated, even they now exist and have the power to alleviate the pain in people's lives. Thank you for your comment, Best Wishes, The Editors, Hdiabetes.com

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